RecruitingPhase 3NCT07231497

Cognitive Strategies in Early Psychosis 1

Sponsor

University of Minnesota

Enrollment

103 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Participants Cognition

Summary

The goal of this clinical is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. The investigators will ask people who do not have psychosis to take a single dose of modafinil and then complete some brain games on the computer that measure decision making. They hope to improve our understanding of psychosis to help people in the future. The main research questions are: Does a single dose of modafinil change how people play the brain games? Does a single dose of modafinil change brain activity? Participants will: Complete an interview and self-report questionnaires. Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test. Take a single dose of modafinil. Complete brain games while wearing an electroencephalography (EEG) cap, before and after taking the single dose of modafinil. EEG measures electrical activity in the brain.

Eligibility

Min Age: 18 YearsMax Age: 35 Years

Inclusion Criteria6

English proficiency, as determined by staff observation and participant self-report
Estimated IQ at or above 70, as estimated by the cognitive assessments
Is clinical stable, defined as outpatient status for at least one month prior to study participation
Has clinically stable doses of medication for at least one month prior to study participation as determined by the PI
Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have major increases or decreases in dosses, or additions or removal of medications in the past 30 days
Participants are to have no changes to medications in the past 7 days before study medication administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).

Exclusion Criteria48

Medical criteria:
Presence of the following medical concerns, as determined by the study PI:
Major neurological disorder
History of head injury with or without prolonged consciousness
Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating
History of any of the following as reported by the participant:
Renal impairment, injury, or disease
Hepatic impairment, injury, or disease
Myocardial infarction or heart disease.
The following cardiac symptoms requiring medical follow-up that, in the opinion of the investigator, would impede participation in the study or would put the participant at additional risk by participating
Dsypnea
Palpitations
Orthopnea
Pedal oedema
Significant dizziness
Syncope
Claudication ---Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis
Presence of unmanaged hypertension (\>140/90) or elevated resting heart rate (\>100 bpm)
Abnormal clinical laboratory values:
uACR \> 30 mg/g
creatinine level \>0/95 mg/dL
AST or ALT \>50 U/L
Bilirubin \>1.2 mg/dL
Total Protein \<6 g/dL
Participant is pregnant, planning to become pregnant, or is breastfeeding
Participant cannot pass the visual acuity test (e.g., a score lower than 20/25 on the Snellen)
Takes medications or supplements that have major interactions with modafinil (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin, amphetamine or dextroamphetamine, dexmethylphenidate or methylphenidate)
Has an allergy to modafinil
Is currently taking modafinil as a prescription
Has previously experienced Stevens-Johnson syndrome in response to taking a medication
Mental health criteria:
Meets criteria for severe substance or alcohol use disorder within 3 months of enrollment
Lifetime history of stimulant use disorder
Meets criteria for clinical risk of suicidal behavior, as defined by:
Clinician judgment
Active suicidal ideation at screening or other appointments
Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment
A suicide attempt within 6 months of enrollment
Meets criteria for a depressive episode within the past month as determined by the diagnostic interview or for a severe or extremely severe depressive episode in the abbreviated battery within the past month
Meets DSM-5 criteria for, or reports professional diagnosis of, a psychotic, bipolar, or autism spectrum disorder
Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder
Is prescribed psychotropic medications or takes supplements with psychotropic effects (e.g., Nootropics)
Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating
Other Criteria:
Unable or unwilling to provide informed consent
Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
Participant is illiterate
Have engaged in significant cognitive training, in the opinion of the PI, in the last year